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VX950 - Time to Market?
I'm confused about the possible time to market for VX950.
The FDA granted the drug Fast Track status which clears the way for clinical trials. Right now VX950 is in a Phase II and about to open up an even larger Phase II trial for non-responders.
Realistically if SVR data holds up, how soon will the drug be made available for SOC?
CTOAN - You follow this stuff...any comments?
The FDA granted the drug Fast Track status which clears the way for clinical trials. Right now VX950 is in a Phase II and about to open up an even larger Phase II trial for non-responders.
Realistically if SVR data holds up, how soon will the drug be made available for SOC?
CTOAN - You follow this stuff...any comments?
I couldn't wait til tomorrow ? I had to keep looking through (it's just the way I am, I guess.) Thanks for sending me in the right direction! This is from July 2006.
SOURCE
http://seekingalpha.com/article/14401
excerpt from
Vertex Pharmaceuticals Q2 2006 Earnings Conference Call Transcript (VRTX)
Vertex Pharmaceuticals Inc. (VRTX)
Q2 2006 Earnings Conference Call
July 26, 2006 5:00 PM
Andrew McDonald - Thinkequity
Okay, that was my final question is what's the design of the PROVE 3 study as you have it now?
John J. Alam
It's a little early. We are -- we're working with investigators, we will, in finalizing that protocol, they will obviously be a regulatory review as well before that protocol is started. As we always do, given all of those discussions, we'll provide more detail on the design of that study when we start the study.
Andrew McDonald - Thinkequity
Okay and then maybe finally, since treatment failure population represents a significant unmet medical need there, could you file an NDA based on the data that you generate out of PROVE 3 and PROVE 1 and 2?
John J. Alam
What I've stated previously, our primary path to NDA, to the NDA in 2008 is based on having Phase III clinical data in the package and that Phase III study would start in the middle of 2007. The key point there is that we would start the Phase III program in mid-2007 while the Phase II program, all three studies, PROVES 1-3 are ongoing. As the data evolve from those studies and become -- including the control arm data -- become available to us in 2008, there's certainly strong data and as you say, I think you're right, Andrew, in particular in the treatment failure study, strong data there would maybe sufficient to support a filing based on that set of data. At this point, projecting out the specifics of how we would -- whether or not they would be sufficient is obviously a little early."
Source:
http://seekingalpha.com/article/14401
Thanks!
SOURCE
http://seekingalpha.com/article/14401
excerpt from
Vertex Pharmaceuticals Q2 2006 Earnings Conference Call Transcript (VRTX)
Vertex Pharmaceuticals Inc. (VRTX)
Q2 2006 Earnings Conference Call
July 26, 2006 5:00 PM
Andrew McDonald - Thinkequity
Okay, that was my final question is what's the design of the PROVE 3 study as you have it now?
John J. Alam
It's a little early. We are -- we're working with investigators, we will, in finalizing that protocol, they will obviously be a regulatory review as well before that protocol is started. As we always do, given all of those discussions, we'll provide more detail on the design of that study when we start the study.
Andrew McDonald - Thinkequity
Okay and then maybe finally, since treatment failure population represents a significant unmet medical need there, could you file an NDA based on the data that you generate out of PROVE 3 and PROVE 1 and 2?
John J. Alam
What I've stated previously, our primary path to NDA, to the NDA in 2008 is based on having Phase III clinical data in the package and that Phase III study would start in the middle of 2007. The key point there is that we would start the Phase III program in mid-2007 while the Phase II program, all three studies, PROVES 1-3 are ongoing. As the data evolve from those studies and become -- including the control arm data -- become available to us in 2008, there's certainly strong data and as you say, I think you're right, Andrew, in particular in the treatment failure study, strong data there would maybe sufficient to support a filing based on that set of data. At this point, projecting out the specifics of how we would -- whether or not they would be sufficient is obviously a little early."
Source:
http://seekingalpha.com/article/14401
Thanks!
I guess the one thing that is certain is that there will be an increasing volume of data from Prove 1 and Prove 2 [soon?] this year. The more hard data, the more likely that the progress through FDA approval will be more predictable.
I guess its understandable that nobody is going to commit beyond generalities until there is sufficient hard data to support those decisions. I guess all we have right now is some promising early indications.
I guess its understandable that nobody is going to commit beyond generalities until there is sufficient hard data to support those decisions. I guess all we have right now is some promising early indications.
Hi CTON. I didn't even see your note! Thanks again. I'll have to say - I have not listened to the webcast presentations by the company or what their analysts have had to say on those presentations (maybe I need to, eh?) :) Maybe tomorrow?
Thanks again! Happy New Year!
Thanks again! Happy New Year!
FDA fast track is about something totally different....it's apples and oranges. It is about communication, more of it, submitting data in pieces, more guidance, possibility of priority review.
You will never find what you are looking for in there. I have listened to every conference call this company has had over the last 6 years on this, and analyst reports cover this also.
Yahoo does sell some analyst reports, if one wants to spend about $30 on taking the chance it is in there (I don't remember which ones mention it). Or one could call the company and ask.
Some of the archived web calls might cover it also, so one could check them.
You will never find what you are looking for in there. I have listened to every conference call this company has had over the last 6 years on this, and analyst reports cover this also.
Yahoo does sell some analyst reports, if one wants to spend about $30 on taking the chance it is in there (I don't remember which ones mention it). Or one could call the company and ask.
Some of the archived web calls might cover it also, so one could check them.
lmao hahaha
In trying to figure this out and going from one report to the next report to the trial design to the next release back to the financial report back to the end of the third quarter report to the ...BLAAAAH report, that it's probably just best to try to convince myself to repeat after me: What will be will be, what will be will be.:)
Best of luck! I know you all can't wait to hear something more, and soon!
In trying to figure this out and going from one report to the next report to the trial design to the next release back to the financial report back to the end of the third quarter report to the ...BLAAAAH report, that it's probably just best to try to convince myself to repeat after me: What will be will be, what will be will be.:)
Best of luck! I know you all can't wait to hear something more, and soon!
The suggestion that FDA Phase 3 testing could start while Phase 2 tests were still in progress is something I have not been able to confirm. There just don't seem to be any sources for this??
The FDA Fast Track seems to be less than specific:
December 9, 2005
On Thursday, Vertex Pharmaceuticals Inc. announced the Food and Drug Administration has granted its hepatitis C drug "fast track" status, which formalizes agency assistance in drug development and in-process data submissions. FDA grants fast track designation, which can speed up the review process, to therapies that address an unmet need. Vertex's VX-950 therapy, which is in mid-stage human trials, has the potential to shorten the time hepatitis C patients spend on medication, the company said.
Not sure what to make of that, other than the FDA saying that it will actually be responsive, and will assist during the development and testing phases. What is the alternative? Are non-Fast Track applications consigned to the 'ignore' pile??
The FDA Fast Track seems to be less than specific:
December 9, 2005
On Thursday, Vertex Pharmaceuticals Inc. announced the Food and Drug Administration has granted its hepatitis C drug "fast track" status, which formalizes agency assistance in drug development and in-process data submissions. FDA grants fast track designation, which can speed up the review process, to therapies that address an unmet need. Vertex's VX-950 therapy, which is in mid-stage human trials, has the potential to shorten the time hepatitis C patients spend on medication, the company said.
Not sure what to make of that, other than the FDA saying that it will actually be responsive, and will assist during the development and testing phases. What is the alternative? Are non-Fast Track applications consigned to the 'ignore' pile??
The company has talked about phase 3 starting during the end of phase 2. It has been discussed so long, it really isn't given a second thought. More than one there has said it, including Dr. John Alam, if you have heard any of his presentations. You could also look at all old press releases at www.vrtx.com
I see almost no chance this gets marketed before 2009.
I see almost no chance this gets marketed before 2009.
Hi CTON. Thanks a lot for your time and explanation.
Ok- I guess I'm uh... lol - hard headed and stubborn and want .... more? :) What I am looking for is a name or names (other than personal opinions from S&P or SEC) who has stated (since the 9% adverse reactions) that PhaseIII will be launched during phase II. I have seen predictions in earlier statements released from Vertex (generic statements), but I cannot find anything recently (other than financial analysts' opinions) that speak about Phase III launching during PhaseII. NOT that I don
Ok- I guess I'm uh... lol - hard headed and stubborn and want .... more? :) What I am looking for is a name or names (other than personal opinions from S&P or SEC) who has stated (since the 9% adverse reactions) that PhaseIII will be launched during phase II. I have seen predictions in earlier statements released from Vertex (generic statements), but I cannot find anything recently (other than financial analysts' opinions) that speak about Phase III launching during PhaseII. NOT that I don
SVR for type 1 are the only important numbers I am interested in.
What are the SVR numbers for phase 1. It would so helpful if these numbers were published bi-weekly. The fact that so much money has been invested tends to alter the way accurate numbers get published. The question for people living with this horrible question mark hanging over our heads is ' What are my chances with vx 950? ' Do I have a future ? One question please, in currant treatments what amount of SVR is considered probably permanent? My sister was treated for 1 year [not type 1] and has been UD for three years. She was told after 6mo SVR that she was cured.
ps. her side affects were brutal she is a RN and could only work 2 shifts a week. [strong flu and severe arthritis using Peg and Riba
What are the SVR numbers for phase 1. It would so helpful if these numbers were published bi-weekly. The fact that so much money has been invested tends to alter the way accurate numbers get published. The question for people living with this horrible question mark hanging over our heads is ' What are my chances with vx 950? ' Do I have a future ? One question please, in currant treatments what amount of SVR is considered probably permanent? My sister was treated for 1 year [not type 1] and has been UD for three years. She was told after 6mo SVR that she was cured.
ps. her side affects were brutal she is a RN and could only work 2 shifts a week. [strong flu and severe arthritis using Peg and Riba
Hi chc,
I'll answer this one at a time. These answers are pretty much out in the public domain, so I am just rehashing what's out there for the most part.
"Second half of next year would be somewhere around June or July, 2007. OK. Can I ask where are you getting this information on Phase III from ? Do you know this to be a fact? The reason I'm asking is I have been told by someone who I consider to be very up on the trials in VX (that would be McHutchinson's group out of Duke) that VX is not expected to be on the market within at least 3 to 4 years, if that. McH hasn't told me this, but a research coordinator who is very involved in VX has told me this. She blurted it out when I was asking if I could wait ,and she said "OH! VX is not anywhere NEAR market - it'll be at least 3 - 4 years if that" (and this was after the data was just released on .. whatever arm was just released from PhaseII. I guess it was the group who had 12 weeks (where 9% experienced bad reactions). "
Second half of 2007 (it is now next year lol) BEGINS in July. It doesn't necessarily mean it starts in July. It is what their timeline has been for quite a while, and they and analysts have mentioned it often. Her "if that" comment sounds as if they are trying too hard to be cautious. Current estimates do not support that. Estimates from analysts, and the timeline PROVIDING things continue to go well. That is important.
"On this Phase III you are speaking about starting while Phase II is ongoing, are you by any chance talking about PROVE3 (which is - from what I understand - still part of phase II). "
Prove III is the non-responder portion of PHASE 2. They have stated that PHASE 3 will start WHILE PHASE 2 is ongoing. Phase 3 is the final phase before filing for FDA approval. On rare occasions, drugs will get approved after Phase 2. This is probably not a candidate. They are developing a drug with MRK (orphan drug status, no good meds, specific market) that would try for that. NOT 950 in all likelihood. I won't get too deep into FDA issues.
"OK - this takes my thoughts back to a "will be marketed in 2 years." Why, then, would that research coordinator have told me "3 - 4 years, if that?" My note to you, frustrated sounding - is not frustrated on account of anything you have said :) It's merely frustration from trying to figure out the timing of my treatment with what I consider to be THE best shot I would have (VX, if I can wait). "
I don't know who said "will be marketed in 2 years", but after approval, sometimes it takes a while to fill the pipeline especially if a drug is expected to be in demand. Can't afford to run out, for example. That shouldn't be a problem. They are manufacturing product right now, but that also gets more involved. I would prefer to say, that it should be marketed SHORTLY after approval (unless something unforseen happens).
I don't know why one would say that. It could be they just don't know. 4 years is 2011, and that seems pretty unreasonable imho (again, as long as things go as planned, and so far so good). 4 years would mean something didn't go according to plan, and no one can know that right now.
"You said: SVR 12 will be out 3 months after the last news release, from a couple of weeks ago. We should have further SVR data from the earlier trials that they reported on also (5 of 6 had SVR 12)
I don't really understand what you mean by this - isn't VX getting ready to release some more data on what they just released and then more data on subjects dosed for 24 weeks? (I get lost on the arms). And then - won't we still have to wait for more data from follow on all the subjects in Phase II, PROVE1, PROVE2, and PROVE3? (like I said, I'm losing track on all these phases vs PROVES :) "
There is a ton of data that will be released this year. The SVR12 (3 month SVR) will obviously be 3 months after they reported the last data, as they have said that's when release would be. The prelim SVR from the 6 are from earlier trials, but not part of this big one. They have always released data as soon as available.
"Anyhow... I'm just trying to get my ducks in a row as best I can on the knowledge base I have on VX, which I had been following like a hawk until the research coordinator basically threw cold water on the "few years" talk. And so, if you can or feel comfortable doing so, I would be very interested to know where you are getting your information on Phase III beginning with Phase II (because if that is true, then that would mean filing is closer, in my opinion, perhaps, than 3 - 4 years away). "
All of that information is public knowledge, meaning, in SEC filings, conference calls, analyst reports (and I read most of them) plus I have experience in this area. Phase 3 beginning during Phase 2 has been discussed often by them. I don't think they would say that unless they had the ok from the FDA. There is a lot of communication there.
I have followed this drug for about 6 years now. Pretty safe to say I don't think many knew about it 6 years ago. I found it by catching a press release on them, this was before the clinic. So, my time following it is pretty long.
Phase 3 should begin the SECOND HALF of 2007. They plan on filing for approval (based on everyone's estimates) by late 2008. Being fast tracked, those drugs normally have an answer with in 6 months of the PDUFA data (Drug Users Fee Act, which is the day they file for approval).
Thank you, and best of luck to you as well.
Happy New Year all.
I'll answer this one at a time. These answers are pretty much out in the public domain, so I am just rehashing what's out there for the most part.
"Second half of next year would be somewhere around June or July, 2007. OK. Can I ask where are you getting this information on Phase III from ? Do you know this to be a fact? The reason I'm asking is I have been told by someone who I consider to be very up on the trials in VX (that would be McHutchinson's group out of Duke) that VX is not expected to be on the market within at least 3 to 4 years, if that. McH hasn't told me this, but a research coordinator who is very involved in VX has told me this. She blurted it out when I was asking if I could wait ,and she said "OH! VX is not anywhere NEAR market - it'll be at least 3 - 4 years if that" (and this was after the data was just released on .. whatever arm was just released from PhaseII. I guess it was the group who had 12 weeks (where 9% experienced bad reactions). "
Second half of 2007 (it is now next year lol) BEGINS in July. It doesn't necessarily mean it starts in July. It is what their timeline has been for quite a while, and they and analysts have mentioned it often. Her "if that" comment sounds as if they are trying too hard to be cautious. Current estimates do not support that. Estimates from analysts, and the timeline PROVIDING things continue to go well. That is important.
"On this Phase III you are speaking about starting while Phase II is ongoing, are you by any chance talking about PROVE3 (which is - from what I understand - still part of phase II). "
Prove III is the non-responder portion of PHASE 2. They have stated that PHASE 3 will start WHILE PHASE 2 is ongoing. Phase 3 is the final phase before filing for FDA approval. On rare occasions, drugs will get approved after Phase 2. This is probably not a candidate. They are developing a drug with MRK (orphan drug status, no good meds, specific market) that would try for that. NOT 950 in all likelihood. I won't get too deep into FDA issues.
"OK - this takes my thoughts back to a "will be marketed in 2 years." Why, then, would that research coordinator have told me "3 - 4 years, if that?" My note to you, frustrated sounding - is not frustrated on account of anything you have said :) It's merely frustration from trying to figure out the timing of my treatment with what I consider to be THE best shot I would have (VX, if I can wait). "
I don't know who said "will be marketed in 2 years", but after approval, sometimes it takes a while to fill the pipeline especially if a drug is expected to be in demand. Can't afford to run out, for example. That shouldn't be a problem. They are manufacturing product right now, but that also gets more involved. I would prefer to say, that it should be marketed SHORTLY after approval (unless something unforseen happens).
I don't know why one would say that. It could be they just don't know. 4 years is 2011, and that seems pretty unreasonable imho (again, as long as things go as planned, and so far so good). 4 years would mean something didn't go according to plan, and no one can know that right now.
"You said: SVR 12 will be out 3 months after the last news release, from a couple of weeks ago. We should have further SVR data from the earlier trials that they reported on also (5 of 6 had SVR 12)
I don't really understand what you mean by this - isn't VX getting ready to release some more data on what they just released and then more data on subjects dosed for 24 weeks? (I get lost on the arms). And then - won't we still have to wait for more data from follow on all the subjects in Phase II, PROVE1, PROVE2, and PROVE3? (like I said, I'm losing track on all these phases vs PROVES :) "
There is a ton of data that will be released this year. The SVR12 (3 month SVR) will obviously be 3 months after they reported the last data, as they have said that's when release would be. The prelim SVR from the 6 are from earlier trials, but not part of this big one. They have always released data as soon as available.
"Anyhow... I'm just trying to get my ducks in a row as best I can on the knowledge base I have on VX, which I had been following like a hawk until the research coordinator basically threw cold water on the "few years" talk. And so, if you can or feel comfortable doing so, I would be very interested to know where you are getting your information on Phase III beginning with Phase II (because if that is true, then that would mean filing is closer, in my opinion, perhaps, than 3 - 4 years away). "
All of that information is public knowledge, meaning, in SEC filings, conference calls, analyst reports (and I read most of them) plus I have experience in this area. Phase 3 beginning during Phase 2 has been discussed often by them. I don't think they would say that unless they had the ok from the FDA. There is a lot of communication there.
I have followed this drug for about 6 years now. Pretty safe to say I don't think many knew about it 6 years ago. I found it by catching a press release on them, this was before the clinic. So, my time following it is pretty long.
Phase 3 should begin the SECOND HALF of 2007. They plan on filing for approval (based on everyone's estimates) by late 2008. Being fast tracked, those drugs normally have an answer with in 6 months of the PDUFA data (Drug Users Fee Act, which is the day they file for approval).
Thank you, and best of luck to you as well.
Happy New Year all.
Hi again. After I wrote my note to you, I went on a search trying to find more about this "PROVE3" I was talking about (I was beginning to confuse myself lol), and I found this (below) in their press release (the lastest one). I knew I had read something about PROVE3, but I haven't seen anything that I can remember about PhaseIII. That's why I asked you if perhaps you meant PROVE3 (vs. phaseIII.)
And when you said "next year", did you mean 2007 or 2008?
OK... thanks, and if you can still back to me I'd appreciate it. Anything and everything I can learn on VX, I so appreciate it.
SOURCE: http://www.vrtx.com/Pressreleases2006/pr102706.html
EXCERPT:
Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication, and is one of the most advanced investigational agents in development that specifically targets HCV. Vertex is conducting a global Phase 2b clinical development program for telaprevir consisting of three large clinical trials that are expected to enroll approximately 1000 patients with HCV at clinical centers in the United States and Europe. Vertex completed enrollment in the 260-patient, U.S.-based PROVE 1 trial in September. The PROVE 2 trial is underway in Europe and is expected to complete enrollment by year-end with approximately 320 patients. Also in the fourth quarter, Vertex expects to initiate PROVE 3, a clinical trial of telaprevir that will enroll more than 400 treatment-experienced patients. In clinical trials, telaprevir is being dosed as 750 mg every eight hours in combination with pegylated interferon alfa-2a (Pegasys
And when you said "next year", did you mean 2007 or 2008?
OK... thanks, and if you can still back to me I'd appreciate it. Anything and everything I can learn on VX, I so appreciate it.
SOURCE: http://www.vrtx.com/Pressreleases2006/pr102706.html
EXCERPT:
Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication, and is one of the most advanced investigational agents in development that specifically targets HCV. Vertex is conducting a global Phase 2b clinical development program for telaprevir consisting of three large clinical trials that are expected to enroll approximately 1000 patients with HCV at clinical centers in the United States and Europe. Vertex completed enrollment in the 260-patient, U.S.-based PROVE 1 trial in September. The PROVE 2 trial is underway in Europe and is expected to complete enrollment by year-end with approximately 320 patients. Also in the fourth quarter, Vertex expects to initiate PROVE 3, a clinical trial of telaprevir that will enroll more than 400 treatment-experienced patients. In clinical trials, telaprevir is being dosed as 750 mg every eight hours in combination with pegylated interferon alfa-2a (Pegasys
Hi, couldn't think. Nice to meet you. Always good to see someone who knows some things about VX. If you can, I would like to ask you for some clarification because I'm trying to learn all I can before I make my decision on treating with HCV 796 slated to begin .. who knows - maybe latter part of Feb.)
OK ... back to you said:
"Also, phase III for 950 is expected to start WHILE phase II is ongoing, and should be the second half of next year."
Second half of next year would be somewhere around June or July, 2007. OK. Can I ask where are you getting this information on Phase III from ? Do you know this to be a fact? The reason I'm asking is I have been told by someone who I consider to be very up on the trials in VX (that would be McHutchinson's group out of Duke) that VX is not expected to be on the market within at least 3 to 4 years, if that. McH hasn't told me this, but a research coordinator who is very involved in VX has told me this. She blurted it out when I was asking if I could wait ,and she said "OH! VX is not anywhere NEAR market - it'll be at least 3 - 4 years if that" (and this was after the data was just released on .. whatever arm was just released from PhaseII. I guess it was the group who had 12 weeks (where 9% experienced bad reactions).
On this Phase III you are speaking about starting while Phase II is ongoing, are you by any chance talking about PROVE3 (which is - from what I understand - still part of phase II).
You said: It seems they are still on target for a late 2008 filing, and it should only be a 6 month review time, so sometime in 2009 remains their goal.
OK - this takes my thoughts back to a "will be marketed in 2 years." Why, then, would that research coordinator have told me "3 - 4 years, if that?" My note to you, frustrated sounding - is not frustrated on account of anything you have said :) It's merely frustration from trying to figure out the timing of my treatment with what I consider to be THE best shot I would have (VX, if I can wait).
You said: SVR 12 will be out 3 months after the last news release, from a couple of weeks ago. We should have further SVR data from the earlier trials that they reported on also (5 of 6 had SVR 12)
I don't really understand what you mean by this - isn't VX getting ready to release some more data on what they just released and then more data on subjects dosed for 24 weeks? (I get lost on the arms). And then - won't we still have to wait for more data from follow on all the subjects in Phase II, PROVE1, PROVE2, and PROVE3? (like I said, I'm losing track on all these phases vs PROVES :)
Anyhow... I'm just trying to get my ducks in a row as best I can on the knowledge base I have on VX, which I had been following like a hawk until the research coordinator basically threw cold water on the "few years" talk. And so, if you can or feel comfortable doing so, I would be very interested to know where you are getting your information on Phase III beginning with Phase II (because if that is true, then that would mean filing is closer, in my opinion, perhaps, than 3 - 4 years away).
Ok . thank you, if you have time. Really appreciate it.
And best of luck to all you VX'rs out there! I'm pulling so hard for all of you!
OK ... back to you said:
"Also, phase III for 950 is expected to start WHILE phase II is ongoing, and should be the second half of next year."
Second half of next year would be somewhere around June or July, 2007. OK. Can I ask where are you getting this information on Phase III from ? Do you know this to be a fact? The reason I'm asking is I have been told by someone who I consider to be very up on the trials in VX (that would be McHutchinson's group out of Duke) that VX is not expected to be on the market within at least 3 to 4 years, if that. McH hasn't told me this, but a research coordinator who is very involved in VX has told me this. She blurted it out when I was asking if I could wait ,and she said "OH! VX is not anywhere NEAR market - it'll be at least 3 - 4 years if that" (and this was after the data was just released on .. whatever arm was just released from PhaseII. I guess it was the group who had 12 weeks (where 9% experienced bad reactions).
On this Phase III you are speaking about starting while Phase II is ongoing, are you by any chance talking about PROVE3 (which is - from what I understand - still part of phase II).
You said: It seems they are still on target for a late 2008 filing, and it should only be a 6 month review time, so sometime in 2009 remains their goal.
OK - this takes my thoughts back to a "will be marketed in 2 years." Why, then, would that research coordinator have told me "3 - 4 years, if that?" My note to you, frustrated sounding - is not frustrated on account of anything you have said :) It's merely frustration from trying to figure out the timing of my treatment with what I consider to be THE best shot I would have (VX, if I can wait).
You said: SVR 12 will be out 3 months after the last news release, from a couple of weeks ago. We should have further SVR data from the earlier trials that they reported on also (5 of 6 had SVR 12)
I don't really understand what you mean by this - isn't VX getting ready to release some more data on what they just released and then more data on subjects dosed for 24 weeks? (I get lost on the arms). And then - won't we still have to wait for more data from follow on all the subjects in Phase II, PROVE1, PROVE2, and PROVE3? (like I said, I'm losing track on all these phases vs PROVES :)
Anyhow... I'm just trying to get my ducks in a row as best I can on the knowledge base I have on VX, which I had been following like a hawk until the research coordinator basically threw cold water on the "few years" talk. And so, if you can or feel comfortable doing so, I would be very interested to know where you are getting your information on Phase III beginning with Phase II (because if that is true, then that would mean filing is closer, in my opinion, perhaps, than 3 - 4 years away).
Ok . thank you, if you have time. Really appreciate it.
And best of luck to all you VX'rs out there! I'm pulling so hard for all of you!
I am so glad to see you posting back on this board again. I understand you have time constraints and it sounds like it's better for you sometimes not to be so actively involved but for whatever it's worth, I'm delighted to see you back.
So, while I have you, (if you're still here) can I ask you a quick question? I just recently found out I'm in group B, the 48 week group, but won't find out my viral loads until next week. I am struggling with making the decision as to whether to stay on treatment as a 1A for the whole 48 weeks or stop at 24.
I've read all the studies that I can find that say achieving rvr at 4 weeks may be an indicator that it's ok to stop treating at 24 weeks even for 1a and 1b. I should qualify that. I'm not actually reading the studies, just the abstracts. I'm not sure how to go about getting my hands on the actual studies and don't know that I would fully understand them anyway. I'm referring to Jensen, et al, Abstract ID 65969, Jules Levin's conference report at the AASLD Oct. 06 conference in Boston, and a retrospective study of the Hadzyiannis data done by Jensen and colleagues, the results of which are "almost identical to those obtained by Zeuzem et al".
Across the board, they all seem to say "A lower baseline HCV RNA level was the only significant and independent factor associated with SVR." and "An RVR at week 4 of treatment is the single best predictive factor for an SVR".
So, my question to you is can you explain to me at all why having a low baseline hcv rna level matters if you clear the virus very quickly, as Pam did. She was UD at day 4. I'll know next week which day I was UD. But, if I was UD early on, even though I had a high starting baseline HCV RNA of 10M and 27M one month earlier, how does that factor into it if you clear early on. I don't know if I'm making sense. What I'm trying to say is I don't see what significance the one has to do with the other if you clear early, you're clear. Right? Why would having a lower baseline hcv rna be the only significant and independent factor associated with SVR if it's cleared out early on?
I don't know if you're familiar with these sorts of issues having to do with vertex, but I thought I'd give it a shot?
Any help would be much appreciated. Really glad to see you back.
Char
So, while I have you, (if you're still here) can I ask you a quick question? I just recently found out I'm in group B, the 48 week group, but won't find out my viral loads until next week. I am struggling with making the decision as to whether to stay on treatment as a 1A for the whole 48 weeks or stop at 24.
I've read all the studies that I can find that say achieving rvr at 4 weeks may be an indicator that it's ok to stop treating at 24 weeks even for 1a and 1b. I should qualify that. I'm not actually reading the studies, just the abstracts. I'm not sure how to go about getting my hands on the actual studies and don't know that I would fully understand them anyway. I'm referring to Jensen, et al, Abstract ID 65969, Jules Levin's conference report at the AASLD Oct. 06 conference in Boston, and a retrospective study of the Hadzyiannis data done by Jensen and colleagues, the results of which are "almost identical to those obtained by Zeuzem et al".
Across the board, they all seem to say "A lower baseline HCV RNA level was the only significant and independent factor associated with SVR." and "An RVR at week 4 of treatment is the single best predictive factor for an SVR".
So, my question to you is can you explain to me at all why having a low baseline hcv rna level matters if you clear the virus very quickly, as Pam did. She was UD at day 4. I'll know next week which day I was UD. But, if I was UD early on, even though I had a high starting baseline HCV RNA of 10M and 27M one month earlier, how does that factor into it if you clear early on. I don't know if I'm making sense. What I'm trying to say is I don't see what significance the one has to do with the other if you clear early, you're clear. Right? Why would having a lower baseline hcv rna be the only significant and independent factor associated with SVR if it's cleared out early on?
I don't know if you're familiar with these sorts of issues having to do with vertex, but I thought I'd give it a shot?
Any help would be much appreciated. Really glad to see you back.
Char
Pln, wow, day 4, that is awesome! I am sure you will attain SVR!
I hope you are recovering, from more than the illness, but soon also from the treatment.
Miked,
First, just wanted to note my absence from the forum of late has nothing to do with the forum. I've been quite busy of late, and doing some different things, so it's been partly a lack of time, and frankly, the distraction is good as I think about HCV a little less. Therefore, I find myself looking at the forum less. I'll say this, it is hard to catch up even after several days LOL. If some ask me stuff, and I don't answer, that just means I haven't been in here, but I will try to check in once in a while. It's funny, but the less I think about it, and the forum is a reminder, I think the better my mind is at least. I guess that's a little strange. Maybe not.
I guess it is an occult issue, and that is one thing that has really been on my mind. So much so, that I actually called VRTX once and asked if they would monitor for that in trials. Keep in mind, these weren't scientists I was speaking to, just pr, but I was told no. IMHO, they should, as it would be a no-lose proposition. If it doesn't, then it isn't any different than the current meds, if it does, it's a plus.
Small molecule drugs, from what I hear, and I don't know this for sure at all, are supposed to be able to deal with that issue better than current treatment. That is theoretical though until studies are done, and I wish they'd do them.
FWIW, the 5 out of 6 that got SVR12, I feel those based on current studies, should have an excellent chance for durable SVR. What I am interested in is 950 without riba in Europe.
Happy New Year and good health to all, and be well.
I hope you are recovering, from more than the illness, but soon also from the treatment.
Miked,
First, just wanted to note my absence from the forum of late has nothing to do with the forum. I've been quite busy of late, and doing some different things, so it's been partly a lack of time, and frankly, the distraction is good as I think about HCV a little less. Therefore, I find myself looking at the forum less. I'll say this, it is hard to catch up even after several days LOL. If some ask me stuff, and I don't answer, that just means I haven't been in here, but I will try to check in once in a while. It's funny, but the less I think about it, and the forum is a reminder, I think the better my mind is at least. I guess that's a little strange. Maybe not.
I guess it is an occult issue, and that is one thing that has really been on my mind. So much so, that I actually called VRTX once and asked if they would monitor for that in trials. Keep in mind, these weren't scientists I was speaking to, just pr, but I was told no. IMHO, they should, as it would be a no-lose proposition. If it doesn't, then it isn't any different than the current meds, if it does, it's a plus.
Small molecule drugs, from what I hear, and I don't know this for sure at all, are supposed to be able to deal with that issue better than current treatment. That is theoretical though until studies are done, and I wish they'd do them.
FWIW, the 5 out of 6 that got SVR12, I feel those based on current studies, should have an excellent chance for durable SVR. What I am interested in is 950 without riba in Europe.
Happy New Year and good health to all, and be well.
Hi, I was wondering how you have been... I know you watch vx, and you have helped me in the past, for that I thank you.. I have 2 more shots then I am done, 24 weeks,, wow, time flies when you are having fun. I have been UND since day 4. Will post more later. Happy new year. Pam
Kalio 1, in your above referenced chicken-egg scenario, one may question whether it was a chicken or an egg.
You stated, "I believe BILN2061 was well into Phase 3 when it was yanked from human testing - and I don't think it had nearly the overt sx that VX950 does."
I would hardly consider three tests, consisting of a total of 51 patients who took the compound for a total of TWO days, a phase III clinical trial. Did you mean phase I, or perhaps something else?
http://www.hepatitis-central.com/mt/archives/2004/12/biln_2061_for_h.html
--pf
You stated, "I believe BILN2061 was well into Phase 3 when it was yanked from human testing - and I don't think it had nearly the overt sx that VX950 does."
I would hardly consider three tests, consisting of a total of 51 patients who took the compound for a total of TWO days, a phase III clinical trial. Did you mean phase I, or perhaps something else?
http://www.hepatitis-central.com/mt/archives/2004/12/biln_2061_for_h.html
--pf
Sigh...I misquoted desrt for Kalio 1. The intent however, remains the same.
To err is human, to forgive, divine.
peace out --pf
To err is human, to forgive, divine.
peace out --pf
Thanks for your reply and information.
Never thought of the Mole theory but you could be right.
I'm really looking forward to reading the SVR data when it comes out. Who cares if everyone is UND if the bug comes back.
One thing that I wanted to ask you is, "What do you think about the recent report of people with SVR still having replicating virus in their livers?" My question is do think that a PI like VX950 will also halt the replication?
For what it's worth I always appreciate your research and am clueless why people on the board beat you up. Keep in touch.
Mike
Never thought of the Mole theory but you could be right.
I'm really looking forward to reading the SVR data when it comes out. Who cares if everyone is UND if the bug comes back.
One thing that I wanted to ask you is, "What do you think about the recent report of people with SVR still having replicating virus in their livers?" My question is do think that a PI like VX950 will also halt the replication?
For what it's worth I always appreciate your research and am clueless why people on the board beat you up. Keep in touch.
Mike
Miked,
It's been quite a while since I have even checked the forum, and it looks like I missed a lot of drama. For that I am glad.
First off, BILN was in phase 1B. I don't know where that phase 3 stuff came from. They have never explicitely stated why they stopped, but it seems to be cardio-tox issues at higher doses in monkeys IIRC.
Also, phase III for 950 is expected to start WHILE phase II is ongoing, and should be the second half of next year. It seems they are still on target for a late 2008 filing, and it should only be a 6 month review time, so sometime in 2009 remains their goal. SVR 12 will be out 3 months after the last news release, from a couple of weeks ago. We should have further SVR data from the earlier trials that they reported on also (5 of 6 had SVR 12)
Since I have not been here, and I have only scanned some of the talk above, I want to throw in my 2 cents based on limited reading/understanding/knowledge of what has been going on.
First, this is the internet (I know, news flash). This creates issues that never existed before. ALL drug companies want trial information blinded, because there are too many problems when bits and pieces come out, misunderstandings, etc. Any scientist will tell you, the process must be untainted, and I imagine many people talking might be seen as possibly influencing others, or info getting out to certain segments of the population, but not all. While I have read and appreciated the updates from those on trials, I had mixed feelings from the start. I said so a long time ago. I doubt VRTX has a mole here, but then again, I don't really know the story that has been apparently ongoing here. But, I am just about 100% sure they READ the board. Oh, and when I do come in, I will still look for how everyone in the trial is doing, and everyone else that I have gotten to know in here.
Happy New Year everyone!
It's been quite a while since I have even checked the forum, and it looks like I missed a lot of drama. For that I am glad.
First off, BILN was in phase 1B. I don't know where that phase 3 stuff came from. They have never explicitely stated why they stopped, but it seems to be cardio-tox issues at higher doses in monkeys IIRC.
Also, phase III for 950 is expected to start WHILE phase II is ongoing, and should be the second half of next year. It seems they are still on target for a late 2008 filing, and it should only be a 6 month review time, so sometime in 2009 remains their goal. SVR 12 will be out 3 months after the last news release, from a couple of weeks ago. We should have further SVR data from the earlier trials that they reported on also (5 of 6 had SVR 12)
Since I have not been here, and I have only scanned some of the talk above, I want to throw in my 2 cents based on limited reading/understanding/knowledge of what has been going on.
First, this is the internet (I know, news flash). This creates issues that never existed before. ALL drug companies want trial information blinded, because there are too many problems when bits and pieces come out, misunderstandings, etc. Any scientist will tell you, the process must be untainted, and I imagine many people talking might be seen as possibly influencing others, or info getting out to certain segments of the population, but not all. While I have read and appreciated the updates from those on trials, I had mixed feelings from the start. I said so a long time ago. I doubt VRTX has a mole here, but then again, I don't really know the story that has been apparently ongoing here. But, I am just about 100% sure they READ the board. Oh, and when I do come in, I will still look for how everyone in the trial is doing, and everyone else that I have gotten to know in here.
Happy New Year everyone!
Guys, as always thanks for the additional data points.
Right after my diagnosis all I wanted to do was get the bug out of my body; it was like an obsession. In business I'm very aggessive at managing situations and getting the results I want. I went into tx bullish and somewhat naive. After 32 weeks of side effects and failed tx, I was humbled.
This time around I'm trying to be much smarter with how I treat and what are the costs (family, business, health, etc.).
Hopefully I'll be invited to join the VX950 trial in the beginning of the year and evaluate all the issues to treating.
I know that I can come here to ask questions and get support.
Again, thanks and Happy New Year.
Mike
Right after my diagnosis all I wanted to do was get the bug out of my body; it was like an obsession. In business I'm very aggessive at managing situations and getting the results I want. I went into tx bullish and somewhat naive. After 32 weeks of side effects and failed tx, I was humbled.
This time around I'm trying to be much smarter with how I treat and what are the costs (family, business, health, etc.).
Hopefully I'll be invited to join the VX950 trial in the beginning of the year and evaluate all the issues to treating.
I know that I can come here to ask questions and get support.
Again, thanks and Happy New Year.
Mike
Yeah, I know it is :( I got kind of worried about that, too, (when my vision started getting worse and worse this past few year and it was apparent I needed to see the eye doc.) I was squinting at everything I tried to read. I didn't know how bad my vision had gotten until I put those new glasses on! LOL! I could see EVERYTHING! I have not had floaters, yet. Well, maybe once or twice in the past few years -- few seconds I saw a little strange white thing floating across my field of vision, but it went away fast. I've heard some people see them all day; that would be awful! When I had the eye exam done last month (hadn't had one in at least 15 years) the doc said "well, no disease process going on in there, which is good news - you have simply reached the ripe old age of presbyopia." (I thought - whew, thank god for just presbyopia! :)
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